The Patented Medicine Prices Review Board has published draft guidelines, including new factors for setting patented drug prices and an updated list of reference countries for Canada to compare its prices.
The guidelines were updated to address the federal government’s final amendments to the PMPRB rules, which were released in August. The board is seeking comment from stakeholders until Jan. 20, 2020.
Read: Feds announce final changes to Canadian drug pricing regulations
“The PMPRB is committed to hearing from Canadians on how it can continue to ensure they are protected from excessively priced patented drugs and looks forward to receiving constructive and meaningful feedback on the proposed changes to its guidelines,” said Mitchell Levine, the PMPRB’s chairperson, in a news release.
The draft guidelines officially removed Switzerland and the U.S. — the only two countries with higher patented drug prices than Canada — as reference countries, and added Australia, Belgium, Japan, the Netherlands, Norway and Spain.
Drugs that received a drug information number after Aug. 21, 2019 will now undergo a new price test process, under which the PMPRB will consider whether the drug’s price reflects its value for patients and the size of the drug’s market in Canada. All medicines with a DIN issued before Aug. 21 will be evaluated under the previous process.
Read: What will PMPRB drug pricing changes mean for plan sponsors?
The draft guidelines will also require drug manufacturers to submit information on the actual market price of their medications and not just the list price. They also include separate price ceilings for the list and rebated prices of patented medicines, and will give drug manufacturers more freedom to change their prices year-to-year as long as they don’t exceed either applicable maximum price.
In addition, the guidelines will allow a 50 per cent increase in the maximum rebate price for drugs that treat rare diseases — those that are found in less than one in 2,000 Canadians — to “reflect the prevailing revenue premium these medicines currently realize over non-rare disease medicines.”
The PMPRB will also have a new reassessment process for medicines that might warrant a higher or lower ceiling price based on changing market conditions.